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Using milrinone to improve heart function in infants after PDA closure

Milrinone for Prevention of Post-ligation Cardiac Syndrome Trial

Phase 3 Interventional NICHD Neonatal Research Network · NCT06679855

This study is testing if the heart medication milrinone can help improve heart function and reduce risks for infants after they have surgery to close a heart vessel called the PDA.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment316 (estimated)
AgesN/A to 3 Months
SexAll
SponsorNICHD Neonatal Research Network Research network
Locations19 sites (Birmingham, Alabama and 18 other locations)
Trial IDNCT06679855 on ClinicalTrials.gov

What this trial studies

This Phase 3 clinical trial aims to evaluate the effectiveness of milrinone in improving heart function in infants following patent ductus arteriosus (PDA) closure. Infants will be randomly assigned to receive either milrinone or a placebo saline solution shortly after the procedure. The study will monitor the infants closely for side effects and assess the drug's impact on survival rates and neurodevelopmental outcomes over a two-year period. The goal is to determine if milrinone can reduce the risk of death or post-ligation cardiac syndrome within a week of the procedure.

Who should consider this trial

Good fit: Ideal candidates are infants born at or before 27 weeks gestation who are under 3 months old and require respiratory support due to significant PDA.

Not a fit: Patients with major congenital malformations or significant congenital heart disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve heart function and survival rates in vulnerable infants after PDA closure.

How similar studies have performed: Previous studies have explored similar interventions, but this specific approach using milrinone in this context is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Gestational age at birth ≤27 weeks (and 6 days) and postnatal age \< 3 months at intervention
* Invasive or non-invasive positive pressure respiratory support (does not include low flow nasal cannula)
* Hemodynamically significant PDA with minimum transductal diameter ≥1.0 mm within 2 days of intervention
* Decision by clinical team to proceed with PDA closure via surgical ligation or percutaneous cardiac catheterization based on clinical and echocardiography features of hemodynamic significance.

Exclusion Criteria:

* Any major congenital malformation
* Congenital heart disease (except small (≤1mm) muscular ventricular septal defects, or small/moderate (\<3mm) atrial septal defect)
* Acute renal failure defined by urine output \< 0.5 mL/kg/hour OR rise of serum creatinine by 0.3 mg/dL within 48 hours OR rise of serum creatinine more than 40% above baseline serum creatinine within prior 72 hours.
* Systemic administration of vasodilator/inodilator agents
* Prior history of arrhythmia

Where this trial is running

Birmingham, Alabama and 18 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Post-ligation Cardiac Syndrome
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.